Ultrasound, Skin Permeation

Product Code: NRJ

General & Plastic Surgery Ultrasonic Medical Devices (Miscellaneous)

Definition: Indicated For The Temporary Disruption Of The Outer Layer Of Skin For The Application Of Drugs, Etc.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 878.4410


Radiation TypeAcoustic
Radition SafetyNone
Annual ReportsNo

Products Classified as NRJ

5781Ultrasound, Skin PermeationLow Energy Ultrasound Wound Cleaner.

Total Product Life Cycle (TPLC) Devices

5781Ultrasound, Skin PermeationLow Energy Ultrasound Wound Cleaner.

FDA Consensus Standards

Ultrasound, Skin Permeation [32412]21 CFR §878.4410 🔎

Pre-market Notifications for NRJ

K040525SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000SONTRA MEDICAL INC.

Global Unique Device Identification Database

00810170018862Ultrasound, skin permeation
00810170018848Ultrasound, skin permeation
00810170018831Ultrasound, skin permeation
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.